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Mind-Body Intervention

Tai Chi + Wellness for Gulf War Syndrome (NIGWVI Trial)

N/A

Waitlist Available

Led By Barbara L. Niles, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

One symptom of CMI must be musculoskeletal or joint pain or stiffness of at least 6 months duration (in addition to fatigue or cognitive complaints of the CDC criteria)

Meets criteria for chronic multisymptom illness (CMI) based on CDC criteria characterized by one or more symptoms of at least 6 months duration from at least two of three symptom categories: 1) musculoskeletal pain (muscle pain, joint pain, or stiffness); 2) fatigue; and 3) mood-cognition

Must not have

Major medical, psychiatric, or neurological disorder or has a moderate or severe traumatic brain injury, which could interfere with their ability to safely engage in Tai Chi exercises

Lacks the capacity to provide consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline pcl-5 at 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if Tai Chi and Wellness interventions can help reduce symptoms in Gulf War Veterans.

Who is the study for?

This trial is for Gulf War veterans who have been experiencing musculoskeletal or joint pain, fatigue, and mood-cognition issues for at least six months. Participants must have served in the 1991 Gulf War, meet CDC criteria for chronic multisymptom illness (CMI), speak English, not plan to move within three months, and be able to access a computer for telehealth sessions.

What is being tested?

The study is testing the effectiveness of Tai Chi and Wellness interventions as treatments for symptoms of Gulf War Veteran's Illness. It aims to determine if these mind-body approaches can reduce symptom severity compared to usual care practices.

What are the potential side effects?

Since Tai Chi and Wellness are non-invasive mind-body interventions focusing on movement and mental health exercises, side effects may include muscle soreness or strain from physical activity. However, they are generally considered low-risk activities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had muscle or joint pain or stiffness for at least 6 months.

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I have long-term symptoms in at least two of these areas: muscle or joint pain, fatigue, mood or thinking problems.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any major health or brain issues that would stop me from safely doing Tai Chi.

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I am unable to understand or sign a consent form.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline pcl-5 at 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline pcl-5 at 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline pcl-5 at 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Brief Pain Inventory - Short Form (BPI) - Pain Interference

Change in Brief Pain Inventory - Short Form (BPI) - Pain Severity

Secondary study objectives

50 Foot Walk Test

Change in Hopkins Verbal Learning Test - Revised (HVLT-R)

Change in Multi-dimensional Fatigue Inventory (MFI-20)

+7 more

Other study objectives

Blood Pressure

Body Mass Index

Change in Chronic Pain Self-Efficacy Scale (CPSS)

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Tai Chi InterventionExperimental Treatment1 Intervention

All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.

Group II: Wellness InterventionActive Control1 Intervention

The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tai Chi Intervention

2014

N/A

~390

0 / 4Eligibility criteria met